BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY PLUS

    MDR report key: 3991179 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08253
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 4, 2014
    Report Date
    May 8, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: A 6947M62 LEAD, IMPLANTED: (B)(6) 2013. A 6725 ACCESSORY, IMPLANTED: (B)(6) 2013. A 5076-58 LEAD, IMPLANTED: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A SYSTEMIC INFECTION AND VEGETATION WAS OBSERVED ON THE LEADS. THE SOURCE OF THE INFECTION WAS REPORTED TO BE UNKNOWN. THE DEVICE AND LEADS WERE REMOVED AND NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467647 ATTAIN ABILITY PLUS DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 429688

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Hospitalization| R DTBA1D4 CRT-D